UMIN-CTR Clinical Trial

Basic information
Public title	A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Acronym	A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Scientific Title	A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Scientific Title:Acronym	A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Region	Japan

Condition
Condition	Stage IIIA or stage IIIB gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A phase II study, that a combination of Docetaxel plus TS-1 is administered to patients with stage IIIA or stage IIIB gastric cancer, postoperatively, is carried out to confirm the feasibility or safety of the treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of the patients who completed the course
Key secondary outcomes	Incidence of adverse events, Time to recurrence, survival, the ratio of the patients who completed the course of TS-1 in a year

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DXT 40mg/m2 is administered by drip infusion on day 1. TS-1 80 mg/m2/day is administered orally between day 1 and day 14. It takes 21 days for the one course
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. histologically proven gastric carcinoma 2. D2 lymph node dissection and curative resection (R0) at the prior surgery 3. patients with stage IIIA or stage IIIB gastric cancer 4. age: 20<= and =<80 years old 5. PS(ECOG): 0 &#8211; 1 6. without any prior radiation therapy, chemotherapy, or hormone therapy 7. patients who can take medicine orally 8. without any other severe diseases WBC 4,000<= and => 12,000/mm3 Neutrocyte 2,000mm3<= Hemoglobin 9.0 g.dl <= Platelet 100,000/mm3 <= Total bilirubin 1.5 mg/dl => AST, ALT normal range in each institute Serum creatinin 1.2 mg/dl >= Creatinin clearance 60 ml/min/body <= **Cockcroft-Gault method is available 9. written informed consents
Key exclusion criteria	1. with double cancer and/or multiple cancer 2. patients who cannot take TS-1 3. patients who need flucitosine, fenitoin or warfarin 4. with allergic history against medicines 5. with severe allergic response against polysolbate 80 6. without any disorder on the chest X-ray or CT, or interstitial pneumonitis or pulmonary fibrosis 7. with other severe diseases (intestinal paralysis, intestinal obstruction, uncontrolled DM, cardiac failure, or liver dysfunction) 8. watery diarrhea 9. pregnant and/or nursing women 10. men who need their children in future 11. liver cirrhosis or active hepatitis 12. cavity fluid which should be taken out 13. doctors' stop not to register to the study
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeyuki Tamura
Organization	Kansai Rosai Hospital
Division name	Department of surgery
Zip code
Address	660-8511 3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL	06-6416-1221
Email

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Furukawa
Organization	Kinki University Faculty of Medicen
Division name	Department of surgery
Zip code
Address	377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL	072-366-0221
Homepage URL
Email

Sponsor
Institute	OGSG
Institute
Department

Funding Source
Organization	NPO Osaka Chinical Study Supporting Organization
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2007 Year 05 Month 17 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s10120-013-0273-7
Publication of results	Published

Result
URL related to results and publications	http://link.springer.com/article/10.1007%2Fs10120-013-0273-7
Number of participants that the trial has enrolled	53
Results	The OS rate at 3 years was 78.4 % [95 % confidence interval (CI), 67.9-90.6 %] and the DFS rate at 3 years was 66.2 % (95 % CI, 54.4-80.7 %).
Results date posted	2022 Year 11 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2013 Year 06 Month 05 Day
Baseline Characteristics	stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy
Participant flow	Fifty-three patients enrolled.
Adverse events	.
Outcome measures	Three-year overall survival (OS) Three-year disease-free survival (DFS)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 10 Month 03 Day
Date of IRB	2007 Year 05 Month 01 Day
Anticipated trial start date	2007 Year 05 Month 01 Day
Last follow-up date	2013 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 05 Month 10 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000849